A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection

Novartis Pharmaceuticals11 enrolled

Overview

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study. cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cure Rate

Interventions

KAE609DRUG

KAE609 75mg single dose

KAE609DRUG

KAE609 150mg single dose

KAE609DRUG

KAE609 225mg single dose

KAE609

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients aged 20 to 60 years * Presence of mono-infection of P. falciparum * Weight between 40 kg to 90 kg Exclusion Criteria: * Patients with signs and symptoms of severe/complicated malaria * Mixed Plasmodium infection * Presence of other serious or chronic clinical condition requiring hospitalization. * Severe malnutrition * Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Locations (4)

Novartis Investigative Site

Ratchabari, Thailand

Novartis Investigative Site

Si Sa Ket, Thailand

Novartis Investigative Site

Tak, Thailand

Novartis Investigative Site

Hanoi, Vietnam

Outcomes

Primary Outcomes

28-day Cure Rate

28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).

Time frame: Day 28

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.